Garmin PACT (Physical Activity Tracking in Type 1 Diabetes Using Garmin Vivosmart)

Type 1 Diabetes Clinical Trial

Official title:

Garmin PACT (Physical Activity Tracking)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05992350
• Other study ID #: STUDY00002582
• Status: Recruiting
• Start date: January 16, 2024
• Est. completion date: November 2025

Study information

• Verified date: March 2024
• Source: Children's Mercy Hospital Kansas City
• Contact: Priscilla Connell, MPH
• Phone: 816-601-4543
• Email: pcconnell[@]cmh.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this observational study is to test the Garmin Vivosmart in children and youth (8-21) with Type 1 Diabetes (T1D) and their parents. The main questions it aims to answer are:

• Does the Garmin Vivosmart increase physical activity (PA)?

• Does the Garmin Vivosmart improve T1D status

Participants will:

• Wear the Garmin Vivosmart (4 or higher) for a year

• Complete surveys at the beginning, middle and end of participation asking about your T1D, T1D management, and PA

• Parents of children will also complete similar surveys about T1D

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: November 2025
• Est. primary completion date: November 2025
• Gender: All
• Age group: 8 Years to 21 Years

Eligibility

Inclusion Criteria:

• Participants aged 8-21 years of age and/or parent of participant aged 8-17 years of age

• Participants diagnosed with T1D greater than 6 months ago

• Participants must be patients at the Children's Mercy Kansas City network

Exclusion Criteria:

• Participants who do not meet age criteria above

• Participants who do not have T1D

• Participants who are unwilling to wear the device for at least 6 months

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Other:
• Garmin physical activity tracker
The Garmin physical activity tracker is worn like a watch on the user. The tracker assesses several physical states, indicates when the body is at optimal time for activity or when the body needs to rest. The tracker also monitors stress levels and prompts relaxation when appropriate. The tracker sets goals with participants based on previously completed activity. The tracker alerts participants after a period of inactivity, encourages regular movement throughout the day, and decreases the amount of time spent sedentary.

Locations

Country	Name	City	State
United States	Children's Mercy	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City

Country where clinical trial is conducted

United States, 

References & Publications (4)

Cescon M, Choudhary D, Pinsker JE, Dadlani V, Church MM, Kudva YC, Doyle Iii FJ, Dassau E. Activity detection and classification from wristband accelerometer data collected on people with type 1 diabetes in free-living conditions. Comput Biol Med. 2021 Aug;135:104633. doi: 10.1016/j.compbiomed.2021.104633. Epub 2021 Jul 12. — View Citation

Grimes A, Lightner JS, Eighmy K, Steel C, Shook RP, Carlson J. Decreased Physical Activity Among Youth Resulting From COVID-19 Pandemic-Related School Closures: Natural Experimental Study. JMIR Form Res. 2022 Apr 15;6(4):e35854. doi: 10.2196/35854. — View Citation

Jaggers JR, McKay T, King KM, Thrasher BJ, Wintergerst KA. Integration of Consumer-Based Activity Monitors into Clinical Practice for Children with Type 1 Diabetes: A Feasibility Study. Int J Environ Res Public Health. 2021 Oct 10;18(20):10611. doi: 10.3390/ijerph182010611. — View Citation

Ozaslan B, Patek SD, Breton MD. Impact of Daily Physical Activity as Measured by Commonly Available Wearables on Mealtime Glucose Control in Type 1 Diabetes. Diabetes Technol Ther. 2020 Oct;22(10):742-748. doi: 10.1089/dia.2019.0517. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Moderate to Vigorous Physical Activity (MVPA) Amount	Minutes per Day of MVPA	Up to 365 days +- 30 days
Primary	Diabetic Ketoacidosis (DKA) Admission	Rate of hospitalization for diabetic ketoacidosis	90 days +- 30 days
Primary	Diabetic Ketoacidosis (DKA) Admission	Rate of hospitalization for diabetic ketoacidosis	180 days +- 30 days
Primary	Diabetic Ketoacidosis (DKA) Admission	Rate of hospitalization for diabetic ketoacidosis	365 +-30 days
Primary	Change in Time in Range	Time where blood glucose is in an appropriate range (and other glucose measurements)	Over 90, 180, and 365 +- 30 days
Primary	Predicted Change	machine learning models to predict change in HbA1c, DKA admissions, and change in Time in Range	90 +- 30 days
Primary	Predicted Change	machine learning models to predict change in HbA1c, DKA admissions, and change in Time in Range	180 +- 30 days
Primary	Predicted Change	machine learning models to predict change in HbA1c, DKA admissions, and change in Time in Range	365 +- 30 days
Primary	Minutes of Sleep per Day	Minutes of Sleep per Day	Up to 365 days +- 30 days
Secondary	Self Reported Physical Activity	Self-reported physical activity via the International Physical Activity Questionnaire Short Form (IPAQ-SF), no min or max, recording the amount of time spent in MVPA in the past week, higher amounts are better.	0 months
Secondary	Self Reported Physical Activity	Self-reported physical activity via the International Physical Activity Questionnaire Short Form (IPAQ- SF), no min or max, recording the amount of time spent in MVPA in the past week, higher amounts are better.	6 months
Secondary	Self Reported Physical Activity	Self-reported physical activity via the International Physical Activity Questionnaire Short Form (IPAQ-SF), no min or max, recording the amount of time spent in MVPA in the past week higher amounts are better.	12 months
Secondary	Self Reported T1D Management	Hypoglycemic Fear Scale (HFS-II) min 0 max 132, higher scores are a worse outcome	0 months
Secondary	Self Reported T1D Management	Hypoglycemic Fear Scale (HFS-II) min 0 max 132, higher scores are a worse outcome	6 months
Secondary	Self Reported T1D Management	Hypoglycemic Fear Scale (HFS-II) min 0 max 132, higher scores are a worse outcome	12 months
Secondary	Self Reported T1D Management	Hypoglycemic Fear Scale II for Parents (HFS-P) min 0 max 143, higher scores are a worse outcome	0 months
Secondary	Self Reported T1D Management	Hypoglycemic Fear Scale II for Parents (HFS-P) min 0 max 143, higher scores are a worse outcome	6 months
Secondary	Self Reported T1D Management	Hypoglycemic Fear Scale II for Parents (HFS-P) min 0 max 143, higher scores are a worse outcome	12 months
Secondary	Change in self reported physical activity levels	Change in self reported physical activity levels via self-report with the IPAQ survey no min or max, recording the amount of time spent in MVPA in the past week, higher amounts are better.	Between 0, 6, and 12 months
Secondary	Change in how participants feel about episodes of hypoglycemia	Change in how participants feel about episodes of hypoglycemia measured via the Hypoglycemic Fear Scale II (HFS-II) min 0 max 132, higher scores are a worse outcome	Between 0, 6, and 12 months
Secondary	Change in how parents feel about episodes of hypoglycemia in their children	Change in how parents feel about episodes of hypoglycemia in their children wearing the Garmin physical activity tracker via the Hypoglycemic Fear Scale II for Parents (HFS-P) min 0 max 143, higher scores are a worse outcome	Between 0, 6, and 12 months